Actively Recruiting
Body Composition Assessment and Monitoring in Inflammatory Bowel Disease
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-09-09
48
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead Sponsor
G
Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, prospective observational study aiming to describe changes in body composition (specifically, percentage of lean mass and phase angle) in patients with active inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The study will recruit patients with a confirmed IBD diagnosis who are starting biologic therapy or Janus kinase inhibitors (JAKi) to induce clinical remission. Body composition will be assessed using bioelectrical impedance analysis (BIA) at baseline (time 0), 24 weeks, and 52 weeks after starting medication. Clinical disease activity, endoscopic findings, and laboratory data will also be collected at various time points if available. The study has a total duration of 36 months, including a 12-18 month patient inclusion period and a 12-month follow-up. Patients will provide informed consent, and all treatment decisions will follow standard clinical practice, as this is a non-interventional observational study.
CONDITIONS
Official Title
Body Composition Assessment and Monitoring in Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any sex.
- Age between 18 and 64 years.
- Definitive diagnosis of Crohn's disease or ulcerative colitis for more than 3 months.
- Moderate-to-severe disease activity requiring biologic or JAKi therapy to induce remission.
You will not qualify if you...
- Unclassified inflammatory bowel disease.
- History of intestinal resection for IBD except ileocecal resection.
- Short bowel syndrome.
- Medical treatment needed for postsurgical recurrence.
- Active perianal disease.
- Medical treatment needed for intestinal stricture.
- Previous participation in a clinical trial for IBD medication.
- Vigorous physical activity over 6 METs more than 3 days per week.
- Habitual alcohol consumption over 1 standard drink per day.
- Diabetes with poor glycemic control.
- Chronic use of diuretics.
- Chronic kidney disease on dialysis.
- Presence of dependent edema or ascites.
- Having a cardiac pacemaker.
- Pregnant or breastfeeding.
- Unable to give informed consent.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Unidad de Enfermedad Inflamatoria Intestinal
Barcelona, Spain, 08025
Actively Recruiting
Research Team
A
Antonio Giordano, MD, MSc, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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